Key Facts

Remote From:

Belgium

Category: Research Assistant

Full time

Senior (5-10 years)

Dutch

Hard Skills

Compliance Management Medical Oncology Data Integrity Web Administration Site Assessment Clinical Research Coordination Issue Tracking Remote Administration

Other Skills

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Communication
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Time Management
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Teamwork
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Prioritization
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Social Skills
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Report Writing
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Problem Solving

Roles & Responsibilities

Bachelor’s degree, nursing degree, or equivalent; science discipline preferred.
Minimum 4 years onsite trial monitoring experience.
Strong knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (FDA, EMA, PMDA).
Proficiency with IT tools including Microsoft Office, EDC, CTMS, and data repositories; Flemish/Dutch language skills strongly preferred.

Requirements:

Perform site management and monitoring activities, including site qualification, initiation, interim and close-out visits (on-site and remote), and manage drug accountability per protocol.
Collaborate with sponsor functions (CTLs, Study Start-Up, Global Partnerships, Trial Optimization) to support site activation and deliverables, and maintain productive relationships with investigator site staff.
Develop and implement Oversight Monitoring Plan; review study metrics, assess CRA and site performance, conduct oversight visits, and verify data integrity (ALCOA) and study status.
Ensure regulatory files are current, timely submission of study documentation and safety reporting; write monitoring and oversight reports, track and escalate issues; support inspection readiness.

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is currently seeking Senior Clinical Research Associates (SCRA) to join us in Belgium, dedicated to a single sponsor.

The SCRA role is responsible for supporting monitoring and site management activities for the sponsor’s studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and sponsor SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. The SCRA is also responsible for the oversight of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics.

Working as a SCRA at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Please note that this role will involves some cross-border monitoring in Netherlands.

Responsibilities

Site Management and Monitoring Activities:

Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs.
Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
Partner with Clinical Trial Liaison (CTL) and other sponsor functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables.
Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements.

Oversight Monitoring:

Prepare and maintain Oversight Monitoring Plan.
Perform review of study metrics, assess Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits.
Conduct Oversight Monitoring Visits at sites, either independently or alongside other CRAs.
Review site source documentation and verify accurate data capture (ALCOA principles).
Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items.

Documentation and Reporting:

Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.
Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner.
Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents).

Issue Management and Escalation:

Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.
Track, trend, and report issues, escalating them to the appropriate teams when required.

Collaboration and Communication:

Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.
Actively participate in team meetings and process improvement initiatives to enhance study outcomes.

Inspection Readiness

Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables.

Here are a few requirements specific to this advertised role.

Minimum of 4 years onsite trial monitoring experience.

Bachelor’s, nursing degree or equivalent required, science preferred.
Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).
Effective communication and interpersonal skills to build relationships internally and externally.
Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.
Demonstrated ability to deliver clear and concise written reports.
Effective prioritisation and time management skills.
Flemish/Dutch language skills are strongly preferred.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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